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8 Apr 2011

GSK, XenoPort’s RLS Drug Approved by FDA

The FDA has approved tablets developed by GSK and XenoPort for the treatment of moderate-to-severe primary Restless Legs Syndrome.

After  two 12-week trials in adults demonstrating the efficacy in patients, GlaxoSmithKline and XenoPort, Inc. finally received approval from the FDA for Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). 


"Restless Legs Syndrome remains under-recognized, and many patients go untreated as a result,” said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicine Development Center. “GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment for moderate-to-severe primary Restless Legs Syndrome.”

"This significant milestone represents the culmination of XenoPort’s efforts to develop a

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